DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
2. Applicant’s election of Compound I-2 (
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174
192
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) in the reply filed on May 8, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
3. Examination followed guidelines provided by MPEP 803.02. The elected species was obvious over the prior art. Therefore, the Markush claims were rejected and claims to nonelected species were withdrawn from further consideration.
4. Claims 20, 21, 32 and 33 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter. Election was made without traverse in the reply filed on May 8, 2026.
Information Disclosure Statement
5. The information disclosure statement dated July 25, 2024 was in compliance with the provisions of 37 CFR 1.97 and 37 CFR 1.98. The IDS was considered. A signed copy of form 1449 is enclosed herewith
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
6. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 75 recites the broad recitation “cholesterol-lowering medication”, and the claim also recites “atorvastatin, pravastatin, rosuvastatin, lovastatin, and simvastatin” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
7. Claim(s) 1-3, 16-21, 32-34, 51, 58, 69, 75, 79, 83, 85 and 88 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO2016044447 as applied to claims 1-3, 16-21, 32-34, 51, 58, 69, 75, 79, 83, 85 and 88 above, and further in view of Sabbatini et al.
Determining the scope and contents of the prior art
WO 2016044447 teaches treatment of diseases using stimulators of soluble guanylate cyclase. The reference teaches the specific embodiment of compound 30 (page 8) and the treatment of heart failure with preserved ejection fraction (HFPEF, paragraph [00130]). The reference further teaches dosages of 0.01 to 10000 mg/kg which corresponds to the present claims (present claim 51). The reference further teaches the combination with other actives such as ACE inhibitors (present claim 58, reference paragraph [00173]), atorvastatin (present claim 89, reference page 89), losartan (present claim 79, reference page 88), trepostinil (present claim 83, reference page 93), diltiazem (present claim 85, reference page 81). The properties in present claims 34 and 88 are inherent to the structure of the compound.
Ascertaining the differences between the prior art and the claims at issue
The reference does not teach administering the actives for the treatment of HFPEF in post-menopausal women.
Resolving the level of ordinary skill in the pertinent art - considering objective evidence present in the application indicating obviousness
Sabbatini et al. teaches that HFPEF affects 50% of patients with HF and most of them being women. The reference also teaches: “the decline of estrogen at menopause might contribute to the pathogenesis of HFPEF.” Abstract. Therefore, one of ordinary skill in the art has the teaching and suggestion in the references to practice the treatment of WO 2016044447 in the patient population of post-menopausal women. The skilled artisan has a reasonable expectation of success based on the treatment taught in the prior art. For this reason, the present claims are found to be prima facie obvious over the prior art.
Conclusion
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/SUN JAE YOO/Primary Examiner, Art Unit 1621
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